Phase 2 Stomach Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 75 years old.
• People who have signed an informed consent form agreeing to take part in the trial.
• People who have been confirmed by tissue testing to have stomach cancer or cancer at the junction of the stomach and oesophagus that cannot be surgically removed and has either spread to nearby areas or to other parts of the body.
• People whose tumour has been tested for a protein called PD-L1, with results confirmed by the investigating doctor.
• People whose tumour has been tested for HER2 — either showing high HER2 levels (HER2-positive, for Cohorts 1 and 2) or low HER2 levels (HER2-low, for Cohort 3), as confirmed by the investigating doctor (confirm with trial site for exact testing definitions).
• People who have not previously received any systemic (whole-body) anti-cancer treatment.
• People who have at least one tumour that can be measured using standard imaging criteria.
• People whose life expectancy is at least 3 months, as judged by the treating doctor.
• People with a good general level of physical functioning — able to carry out everyday activities with no or only minor limitations (known as ECOG performance status 0 or 1).
• People whose blood counts, liver, kidneys, blood clotting, and heart function all meet the required levels as determined by blood tests and heart assessments (confirm with trial site for specific values).
• Women who have not yet reached menopause and who have a negative pregnancy blood test within 7 days before the first dose, and who agree to use effective contraception during treatment and for 120 days after the last dose.
• People who are able and willing to follow the trial schedule and attend all required follow-up visits.

Who may not be able to join:

• People whose stomach cancer is a different type, such as squamous cell carcinoma, undifferentiated carcinoma, or a mixed type involving other cell types.
• People whose stomach cancer shows no HER2 expression at all.
• People who have active or untreated cancer that has spread to the brain, the lining of the brain or spinal cord, or is compressing the spinal cord.
• People who have had a gastrointestinal perforation (a hole in the gut) or a fistula (an abnormal connection in the digestive tract) within the 6 months before starting the trial, unless it was surgically repaired and the treating doctor considers it fully resolved or stable.
• People with active diverticulitis (inflamed pouches in the bowel), an abdominal abscess, or a blockage in the gastrointestinal tract.
• People who are unable to swallow, have poor nutrient absorption, or have uncontrolled nausea, vomiting, diarrhoea, or other significant digestive problems that would affect how the trial drugs are taken or absorbed.
• People who have had a significant bleeding event within 1 month before starting, such as gastrointestinal bleeding, a bleeding stomach ulcer confirmed by camera examination, or vasculitis (inflammation of blood vessels).
• People with symptomatic fluid build-up in the abdomen that requires drainage, or uncontrolled or large amounts of fluid around the lungs or heart.
• People whose cancer appears to be worsening unacceptably during the screening period, as assessed by the investigating doctor.
• People with a current or documented history of inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.
• People who have had major surgery within 4 weeks before starting the trial and have not fully recovered, or who are expected to need major surgery during the trial.
• People with uncontrolled conditions such as diabetes, high blood pressure, serious lung disease, decompensated liver disease, kidney disease, chest pain, severe heart rhythm problems, severe active stomach ulcers, or other uncontrolled metabolic or systemic disorders.
• People who have been diagnosed with any other cancer within the 5 years before joining the trial (other than the stomach cancer being studied).
• People with severe neurological or psychiatric conditions, including dementia, severe depression, or epilepsy.
• People who are pregnant, breastfeeding, or planning to become pregnant.
• People with existing cardiovascular (heart or blood vessel) disease or significant cardiovascular risk factors.
• People who have previously been treated with immune checkpoint inhibitors, immune cell therapies, or antibody-drug conjugates targeting the immune system.
• People who have received certain immune-modifying treatments or herbal/traditional medicines with anti-cancer indications within 2 weeks before the first dose.
• People whose side effects from previous cancer treatments have not settled to a mild level, with certain exceptions such as hair loss, skin pigmentation changes, mild nerve-related symptoms, or lasting effects from radiotherapy that are unlikely to improve.
• People who require regular use of steroid medicines above a low threshold dose (greater than 10 mg/day of prednisone or equivalent) or other immune-suppressing medicines within 14 days before the first dose, with some specific exceptions (confirm with trial site).
• People with a known history of serious allergic reactions to similar medicines, or known allergies to any of the trial drugs or their ingredients.
• People with known reasons why they cannot take the chemotherapy medicines used in the trial (oxaliplatin and capecitabine for Cohort 1; oxaliplatin, fluorouracil, and leucovorin for Cohorts 2 and 3).
• People with an active autoimmune disease (where the immune system attacks the body) that has required treatment within the past 2 years, or one that the treating doctor considers likely to return.
• People with known lung inflammation (non-infectious pneumonia or interstitial lung disease) that is currently causing symptoms or previously required steroid treatment, or that could make it harder to manage treatment side effects.
• People with an active infection requiring intravenous antibiotics or antifungal treatment within 2 weeks before the first dose, or an unexplained fever during the screening period.
• People who have had, or are planned to have, a solid organ transplant or a bone marrow transplant from a donor.
• People with active hepatitis B or hepatitis C infection.
• People with a known immune deficiency condition or a positive HIV test result.
• People who have received a live vaccine within 28 days before the first dose, or who plan to receive one during the trial.
• People who are currently enrolled in another interventional clinical trial (non-interventional or observational studies may be acceptable — confirm with trial site).
• People who, in the investigating doctor's judgement, have any condition that could increase the risks of the trial treatment or make it difficult to assess results safely.
• People who are otherwise considered unsuitable for the trial by the investigating doctor.

Important: Always verify eligibility with the trial site directly before applying.